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Fulfilling the criteria for CLP classification: the implications for substances under the EU chemicals legislation
Stockholm University, Faculty of Science, Department of Environmental Science.ORCID iD: 0000-0001-5900-221X
Stockholm University, Faculty of Science, Department of Environmental Science.ORCID iD: 0000-0002-9193-1147
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2024 (English)In: Frontiers in Toxicology, E-ISSN 2673-3080, Vol. 6, article id 1452065Article in journal (Refereed) Published
Abstract [en]

The CLP mandates manufacturers and importers to classify substances and mixtures according to hazard criteria, with notifications submitted to the European Chemicals Agency (ECHA). Substances meeting hazard criteria must be appropriately labelled and packaged to communicate hazards effectively. The CLP establishes hazard classification criteria but does not independently prohibit or restrict the use of hazardous chemicals. Instead, it serves as a basis for regulatory obligations in other specific regulations. This study investigates the regulatory implications of meeting hazard criteria under the CLP across EU regulations and directives listed in EU Chemicals Legislation Finder (EUCLEF). The results show that fulfilling criteria for human health hazard classes trigger regulatory obligations in the highest number of regulations/directives, with carcinogenicity, mutagenicity, and reproductive toxicity (CMR) leading to obligations in 19 of 20 pieces of legislation linked to the CLP. Conversely, physical, environmental, and ozone layer hazards are associated with fewer regulations and directives, and lead to fewer prohibitions. The study underscores the pivotal role of the CLP in EU chemical legislation and the need for coherence and consistency across regulations. While regulatory obligations are primarily aimed at substances meeting hazard criteria, the variability in self-classification notifications and limitations in harmonized classification processes were observed. Moreover, the complexity of the regulatory structure poses challenges for stakeholders and policymakers, including inconsistencies, compliance difficulties, and the need for frequent revisions. Addressing these challenges is critical for enhancing regulatory effectiveness and ensuring a more coherent and harmonized approach to chemical management in the EU.

Place, publisher, year, edition, pages
2024. Vol. 6, article id 1452065
Keywords [en]
CLP, hazard classification, hazard criteria, EU legislation, chemical strategy for sustainability
National Category
Environmental Sciences
Research subject
Environmental Sciences; Toxicology
Identifiers
URN: urn:nbn:se:su:diva-227279DOI: 10.3389/ftox.2024.1452065ISI: 001333132400001Scopus ID: 2-s2.0-85206832601OAI: oai:DiVA.org:su-227279DiVA, id: diva2:1843518
Available from: 2024-03-11 Created: 2024-03-11 Last updated: 2025-02-04Bibliographically approved
In thesis
1. Inconsistencies and missing links in EU chemicals legislation
Open this publication in new window or tab >>Inconsistencies and missing links in EU chemicals legislation
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The EU chemicals legislation consists of the Regulation on Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and the Regulation on Classification, Labelling, and Packaging of Substances and Mixtures (CLP), complemented by over fifty regulations and directives regulating specific uses and products. While regulating individual uses may offer a faster and simpler approach to protecting human health and the environment from hazardous chemicals, it can also lead to inconsistencies, such as gaps and overlaps. These inconsistencies may arise for chemicals with multiple uses, each governed by separate legislation.

The overall objective of this work was to understand the links between different pieces of EU chemicals legislation, to identify inconsistencies in the regulation of chemicals covered by multiple regulations and, in particular, to explore the implications of these inconsistencies for the protection of human health and the environment. First, we compared how antimicrobial substances are regulated when used in biocidal products compared to cosmetics (Paper I). The risk assessment of cosmetic preservatives focused solely on human health, omitting environmental data and environmental risk assessment. Once granted, the approval of cosmetic preservatives remained valid indefinitely until revoked by the European Commission, with no requirement to update the dossier based on new information. Based on these findings, we examined whether the approved cosmetic preservatives were hazardous to the aquatic environment or persistent, and if so, whether the risks were efficiently managed by REACH (Paper II). The analysis showed that environmental hazards of cosmetic preservatives and other ingredients are overlooked by the Cosmetic Products Regulation and might not be effectively managed by REACH. Next, the linkage between the CLP and other pieces of chemicals legislation was examined, mapping out regulatory obligations, arising from the new CLP hazard classes for endocrine disruption for human health (ED HH), endocrine disruption for the environment (ED ENV), PBT/vPvB, and PMT/vPvM (Papers III and IV). Meeting criteria for human health hazards under the CLP triggered more regulatory obligations across multiple regulations, compared to when fulfilling the criteria for physical or environmental hazards. Implementation of the new CLP hazard classes will require revision of regulations with existing risk management measures connected to the CLP hazard criteria.

The results and conclusions of the studies included in this thesis highlight the need for addressing the existing inconsistencies in order to strengthen the protection of human health and the environment. The provided recommendations address the need for harmonisation of the chemicals legislation and more efficient management of hazardous chemicals.

Place, publisher, year, edition, pages
Stockholm: Department of Environmental Science, Stockholm University, 2024. p. 27
Keywords
REACH, Cosmetic Products Regulation, Biocidal Products Regulation, CLP, new hazard classes, PBT/vPvB, EDC, PMT/vPvM, endocrine disruptor, Chemicals Strategy for Sustainability
National Category
Environmental Sciences
Research subject
Environmental Sciences
Identifiers
urn:nbn:se:su:diva-227293 (URN)978-91-8014-707-1 (ISBN)978-91-8014-708-8 (ISBN)
Public defence
2024-04-29, De Geersalen, Geovetenskapens hus, Svante Arrhenius väg 14 and online via Zoom, public link is available at the department website, Stockholm, 10:00 (English)
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Available from: 2024-04-04 Created: 2024-03-11 Last updated: 2024-03-26Bibliographically approved

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Kättström, DianaRudén, ChristinaÅgerstrand, Marlene

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